MethodDefs, ValueLists and WhereClauses:

Transcription

1 MethodDefs, ValueLists and WhereClauses: How to Define Data Traceability in an MDR DH03 Judith Goud, Nurocor

2 Agenda Data Traceability Standards Traceability in Clinical Development Systems Conclusion

3 Data Traceability

4 Data Traceability Definition 4

5 Data Traceability Drivers Regulatory requirements The US Food & Drug Administration states in their Study Data Technical Conformance Guide section : it is very important that the results presented in the accompanying study report be traceable back to the original data collected The Japanese Pharmaceutical and Medical Devices Agency Notification on Practical Operations of Electronic Study Data Submission asks in section 3(1)a(v) to:.. explain the traceability between the submitted data (such as the procedures in which both datasets were prepared, the relationship between the variables, and whether there was any information used during the preparation) 5

6 Data Traceability Drivers Business Process Efficiency Collection ecrf Tabulation Analysis LBTPT LBTPT codelist LBTPTNUM LBTPTNUM ATPTN = new value codelist LBTEST LBTESTCD LBORRES LBORRESU LBTEST LBTESTCD LBSTRESN LBSTRESU PARAM PARAMCD AVAL CHGT1* PCHGT1* Table xx.x.xx * --T1 = relative to timepoint where ATPTN = 1 6

7 Standards

8 CDISC Standards Foundational standards defined separately for lifecycle stages Additional metadata needs to be defined to bridge the gaps between the lifecycle stages Define-XML standard is the only CDISC Data Exchange standard designed to describe data traceability 8

9 Define-XML Elements for Data Traceability * elements in blue are additional compared to ODM <ODM> <Study> <GlobalVariables> <MetaDataVersion> <def:annotatedcrf> <def:supplementaldoc> <def:valuelistdef> <ItemRef> <def:whereclauseref> <def:whereclausedef> <RangeCheck> <CheckValue> <ItemGroupDef> <ItemRef> <ItemDef> <CodeListRef> <def:origin> <def:documentref> <def:pdfpageref> <def:valuelistref> <CodeList> <MethodDef> <def:commentdef> <def:leaf> Document(s) that provide(s) the mapping of data collection fields to the variables or discrete variable values contained within the datasets The value list element in combination with the where clause element describes the value level metadata The origin element provides machinereadable connections between variables This element ties the ValueList to the field/variable 9

10 Derivation Example Birth Month and Year BRTHDTC BRTHMO BRTHYY Sex SEX / Female Male Race RACE <ItemGroupDef OID="IG.DM" Domain="DM" Name="DM" <Description> Ethnic <TranslatedText xml:lang="en">demography</translatedtext> ETHNIC American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White Hispanic or Latino Not Hispanic or Latino </Description> Not Reported <ItemRef ItemOID="IT.DM.BRTHDTC" OrderNumber="1" Mandatory="Yes MethodOID="MT.BRTHDTC"/> </ItemGroupDef> <ItemDef OID="IT.DM.BRTHDTC" Name="BRTHDTC" DataType="date" Length="20 SASFieldName="BRTHDTC"> <Description> <TranslatedText xml:lang="en">date/time of Birth</TranslatedText> </Description> <def:origin Type="Derived"> </ItemDef> <MethodDef OID="MT.BRTHDTC" Name="Algorithm to derive BRTHDTC Type="Computation" > <Description> <TranslatedText xml:lang="en">derived from BRTHMO and BRTHYY, appending 01 for the day and concatenated into ISO 8601 format.</translatedtext> </Description> </MethodDef> 10

11 VLM Example <ItemGroupDef OID="IG.VS" Domain="VS Name="VS" <Description> <TranslatedText xml:lang="en">vital Signs</TranslatedText> </Description> <ItemRef ItemOID="IT.VS.VSORRES OrderNumber= 2" Mandatory="Yes"/> </ItemGroupDef> <ItemDef OID="IT.VS.VSORRES" Name="VSORRES" DataType="text Length="30 SASFieldName="VSORRES"> <Description> <TranslatedText xml:lang="en">result or Finding in Original Units</TranslatedText> </Description> <def:origin Type="CRF"> <def:documentref leafid="lf.blankcrf"> <def:pdfpageref PageRefs="11 Type="PhysicalRef"/> </def:documentref> </def:origin> <def:valuelistref ValueListOID= "VL.VS.VSORRES"/> </ItemDef> 11

12 VLM Example (cont.) <def:valuelistdef OID="VL.VS.VSORRES"> <ItemRef ItemOID="IT.VS.VSORRES.DIABP" OrderNumber="1" Mandatory="Yes"> <def:whereclauseref WhereClauseOID="WC.VS.VSTESTCD.DIABP"/> </ItemRef> <ItemRef ItemOID="IT.VS.VSORRES.SYSBP" OrderNumber="2" Mandatory="Yes"> <def:whereclauseref WhereClauseOID="WC.VS.VSTESTCD.SYSBP"/> </ItemRef> </def:valuelistdef> <def:whereclausedef OID="WC.VS.VSTESTCD.DIABP"> <RangeCheck SoftHard="Soft" def:itemoid="it.vs.vstestcd" Comparator="EQ"> <CheckValue>DIABP</CheckValue> </RangeCheck> </def:whereclausedef> <def:whereclausedef OID="WC.VS.VSTESTCD.SYSBP"> <RangeCheck SoftHard="Soft" def:itemoid="it.vs.vstestcd" Comparator="EQ"> <CheckValue>SYSBP</CheckValue> </RangeCheck> </def:whereclausedef> 12

13 Data Traceability in Clinical Development Systems MDM

14 Clinical Development Systems Many systems contain data for parts of the clinical data lifecycle A metadata repository can manage standards across the data lifecycle and is the primary candidate for defining traceability between stages 14

15 Traceability in the MDR: <def:origin> Values: CRF, Derived, Assigned, Protocol, edt, Predecessor Should be defined in context 15

16 Traceability in the MDR: <MethodDef> Unique Name, Type and Description are required 16

17 Value Level Metadata Most often used in Findings domains Providing additional definitions for variables like Result and Unit specific to each value of Test References should capture: whether target variable is mandatory the constraint for each of the values, including comparator check value failure type 17

18 Traceability in the MDR: VLM Mandatory is captured on the context between the SDTM variable and domain The constraint can be captured on the relationship between the collection and tabulation variable 18

19 <def:commentdef> Comments for Define-XML should be facilitated on any element 19

20 MDR Output When all standards and transformational metadata is captured in an MDR it can produce: Define-XML for submission Annotated CRF

21 Conclusion

22 Conclusion A metadata repository is well suited for control and versioning of data traceability and can serve as the single source or truth The repository should hold all information about data elements and all references and transformations the data element was subject to Define-XML provides a good framework of what information should be captured in the MDR to satisfy regulatory reviewers requirements for data traceability The origin, derivation and value level metadata attributes should be managed as context-dependent attributes to facilitate reuse of core data elements 22

23 Any questions?

24 Judith Goud